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Introduction To ICH GCP

The document provides an introduction to ICH-GCP (Good Clinical Practice) guidelines. It discusses the history of research ethics, including key events and documents that shaped ethical standards like the Nuremberg Code, Declaration of Helsinki, and ICH-GCP guidelines. The core principles of ICH-GCP are outlined, including prioritizing subject rights and safety, ensuring proper informed consent, maintaining confidentiality, having qualified investigators, and implementing quality management systems.

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Swapnil Bhowate
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285 views15 pages

Introduction To ICH GCP

The document provides an introduction to ICH-GCP (Good Clinical Practice) guidelines. It discusses the history of research ethics, including key events and documents that shaped ethical standards like the Nuremberg Code, Declaration of Helsinki, and ICH-GCP guidelines. The core principles of ICH-GCP are outlined, including prioritizing subject rights and safety, ensuring proper informed consent, maintaining confidentiality, having qualified investigators, and implementing quality management systems.

Uploaded by

Swapnil Bhowate
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPTX, PDF, TXT or read online on Scribd
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Introduction to ICH-GCP

Research
Re+ Search
Again Search
or
“the use of existing knowledge in a new and creative
way so as to generate new concepts, methodologies and
understandings”

https://www.westernsydney.edu.au/research/researchers/preparing_a_grant_application/dest_definition_of_researc
h
History
605 BC Book of Daniel Veg Vs Non-veg diet

500 BC The Hippocratic Oath- Ethics

1747 scurvy trial conducted by James Lind- huge


problem among sailors at the time.
History to learn
Nuremberg Code, 1947

Kefauver Amendmens 1962 (thalidomide)

Declaration of Helsinki, 1964 → 2013

Belmont Report 1979

ICH GCP guidelines, 1996

Ethical Guidelines for Biomedical Research in Human Subjects (ICMR), 2000


Many cases were like this
The Declaration of Helsinki 1964-2013
The willowbrook state study (to know natural course of infective hepatitis
in children) &

Jewish Chronic Disease Hospital study (to understands body’s ability to


reject cancer cells in debilitated subjects) were examples of unethical
research.

This led the World Medical Association to develop

Declaration of Helsinki.
Declaration of Helsinki
This Declaration has undergone 7 revisions (recent in oct
2013).

Introduced the concept of oversight by an 'independent


committee’ Or Ethics committees “All protocols must be
submitted to an ethics committee for review, which must
be independent of the investigator, the sponsor or any
other kind of undue influence”.
Why GCP
Awareness on critical evaluation of medicinal products

Medical tragedies

1960-70: rapid increase in laws, regulations & guidelines on

Medicinal products

Widening market opportunities for Pharma industry

Duplication of work

Raising cost of health care

Timely Access of Patients to Safe & Effective “New Drugs”

Need to meet public expectation


THE PRINCIPLES OF ICH GCP

2.l Clinical trials should be conducted in accordance with the ethical principles that
have their origin in the Declaration of Helsinki, and that are consistent with GCP
and the applicable regulatory requirement(s).

2.2 Before a trial is initiated, foreseeable risks and inconveniences should be


weighed against the anticipated benefit for the individual trial subject and
society. A trial should be initiated and continued only if the anticipated benefits
justify the risks.

2.3 The rights, safety, and well-being of the trial subjects are the most important
considerations and should prevail over interests of science and society.

E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry
THE PRINCIPLES OF ICH GCP
2.4 The available nonclinical and clinical information on an investigational
product should be adequate to support the proposed clinical trial.

2.5 Clinical trials should be scientifically sound, and described in a clear,


detailed protocol.

2.6 A trial should be conducted in compliance with the protocol that has
received prior institutional review board (IRB)/independent ethics
committee (IEC) approval/favorable opinion.

E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry
THE PRINCIPLES OF ICH GCP
2.7 The medical care given to, and medical decisions made on behalf of,
subjects should always be the responsibility of a qualified physician or, when
appropriate, of a qualified dentist.

2.8 Each individual involved in conducting a trial should be qualified by


education, training, and experience to perform his or her respective task(s).

2.9 Freely given informed consent should be obtained from every subject prior
to clinical trial participation.

2.10 All clinical trial information should be recorded, handled, and stored in a
way that allows its accurate reporting, interpretation, and verification.
E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry
THE PRINCIPLES OF ICH GCP
2.11 The confidentiality of records that could identify subjects should be protected,
respecting the privacy and confidentiality rules in accordance with the
applicable regulatory requirement(s).

2.12 Investigational products should be manufactured, handled, and stored in


accordance with applicable good manufacturing practice (GMP). They should
be used in accordance with the approved protocol.

2.13 Systems with procedures that assure the quality of every aspect of the trial
should be implemented.

E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry
Thank You

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